Bio-Statistical Services
Our Bio-Statistical
Services provide comprehensive statistical support throughout the entire clinical research
lifecycle, ensuring scientifically sound study design, robust data analysis, and regulatory
compliance. Our experienced biostatisticians work closely with sponsors, CROs, and research teams to
deliver accurate, reliable, and submission-ready statistical outputs.
Our Bio-Statistical Services Include:
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Clinical Trial Statistical Planning – Development of statistical
strategies aligned with study objectives and regulatory requirements.
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Sample Size Determination & Power Analysis – Scientifically justified
calculations to optimize study design and ensure adequate statistical power.
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Protocol & Statistical Input – Statistical review and contribution
during protocol development and study planning.
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Statistical Analysis Plan (SAP) Development – Preparation of detailed
SAPs compliant with international regulatory guidelines.
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Randomization & Blinding – Design and generation of randomization
schedules, including stratified and block randomization.
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Interim & Final Statistical Analysis – Comprehensive analysis of
clinical trial data using validated statistical methodologies.
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Clinical Data Analysis – Descriptive, inferential, survival,
longitudinal, and multivariate statistical analyses.
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CDISC-Compliant Statistical Support – Statistical programming and
analysis aligned with CDISC standards (SDTM, ADaM).
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Regulatory Submission Support – Preparation of statistical reports,
tables, listings, figures (TLFs), and documentation for regulatory submissions.
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Safety & Efficacy Analysis – Evaluation of clinical endpoints,
adverse events, and safety profiles.
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Medical Device & Pharmaceutical Studies – Statistical support for
clinical investigations involving pharmaceuticals, biologics, and medical devices.
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Statistical Programming – SAS and R programming for data analysis,
reporting, and regulatory submissions.
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Publication & Research Support – Statistical analysis and
interpretation for scientific publications, manuscripts, and academic research.
Population Pharmacokinetic (PopPK)
Modelling
Our Population
Pharmacokinetic (PopPK) Modelling services provide advanced quantitative analysis to characterize
drug disposition, identify sources of variability, and support informed decision-making throughout
drug development. Using state-of-the-art nonlinear mixed-effects modelling approaches, we evaluate
the influence of demographic, physiological, pathological, and treatment-related covariates on
pharmacokinetic parameters.
Our experienced
pharmacometricians develop robust PopPK models using industry-standard software to support dose
optimization, special population assessments, pediatric extrapolation, exposure-response analysis,
and regulatory submissions. We assist pharmaceutical, biotechnology, and clinical research
organizations in designing efficient clinical studies, reducing development risks, and accelerating
product approvals.
Our Scope Include:
- Population PK model
development and validation
- Covariate identification and
analysis
- Dose optimization and
simulation
- Exposure-response (PK/PD)
modelling
- Model-based clinical trial
design
- Sparse sampling strategy
development
- Pediatric and special
population modelling
- Bioequivalence and biosimilar
pharmacometric support
- Regulatory submission support
(FDA, EMA, MHRA, CDSCO and other global agencies)
- Model diagnostics,
qualification, and reporting
Our scientifically rigorous, regulatory-compliant PopPK modelling solutions enable evidence-based
drug development, improve dosing recommendations, and support successful regulatory interactions
while maximizing the probability of clinical and commercial success.
Why Choose Our Bio-Statistical
Services?
- Experienced team of qualified
biostatisticians
- Expertise across Phase I–IV clinical
trials and medical device studies
- Compliance with ICH-GCP, FDA, EMA,
CDSCO, and ISO standards
- High-quality statistical programming
and validated outputs
- Timely delivery with a focus on
accuracy and regulatory readiness
- Customized solutions tailored to
sponsor and study-specific requirements
At Anacon
Research Pvt. Ltd., we deliver reliable, scientifically robust, and regulatory-compliant
biostatistical solutions that support informed decision-making, successful clinical development, and
efficient regulatory submissions.